Evaluation of Truebeam for Low-Intermediate Risk Prostate Cancer

Prostate Neoplasms Clinical Trial

Official title:

Prospective Evaluation of Truebeam STX Stereotactic Body Radiosurgery for Low and Intermediate Risk Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01581749
• Other study ID #: R12-3104L
• Status: Recruiting
• Phase: Phase 4
• First received: April 18, 2012
• Last updated: March 22, 2016
• Start date: October 2011
• Est. completion date: December 2022

Study information

• Verified date: March 2016
• Source: Main Line Health
• Contact: Department of Radiation Oncology
• Phone: 484-476-3587
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary safety purpose of this study is to estimate the rates of immediate and long-term high grade (grade 3-5) gastrointestinal and genitourinary side effects during the five years after TrueBeam stereotactic body radiotherapy in low-risk and intermediate-risk prostate cancer patients. The primary efficacy purpose is to compare 5 year biochemical disease free survival rates with TrueBeam to 5 year biochemical diseases free survival rates with dose-escalated external beam radiation therapy.

Description:

The prescribed PTV dose of 36.25Gy shall be given in 5 fractions using the Truebeam STx.

At one week after treatment, toxicity and AUA score will be evaluated. At 1 month following treatment, patients will be assessed for acute toxicity, and will fill out AUA form, SF-12, EPIC-26, SHIM and Utilization of Sexual Rx/Devices. At 3, 6, 12, 18, and 24 month intervals (and every 6 months thereafter, through year 5, and annually through year 10, if investigators opt to continue past year 5), patients will be seen and evaluated, including a history, physical exam, ECOG performance status, PSA, toxicity evaluation, and AUA score. In addition, at 6 months, 12 months and annually thereafter, the SF-12, EPIC-26, SHIM and Utilization of Sexual Medications/Devices will be administered. Examination and studies may be done at outside facility.

A prostate biopsy will be performed at time of biochemical or local clinical failure, and is encouraged at 2 years following treatment and at time of distant failure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• histologically proven prostate adenocarcinoma within 1 year of enrollment

• Low risk: Gleason <or=6 & PSA <or=10 & Clinical Stage T1b-T2a,Nx or N0, Mx or M0

• Intermediate risk:Gleason <or=6 & PSA<or=10 & Clinical Stage T2b OR Gleason=7 & PSA<or=10 & Clinical Stage T1b-T2b OR Gleason <or=6 & PSA > 10 & < or =20 & Clinical Stage T1b- T2b, Nx or NO, Mx or M0

• ECOG Performance Status 0-1

• No prior prostate radiation or other definitive therapy

Exclusion Criteria:

• implanted hardware or other material that would prohibit treatment planning or delivery

• chemotherapy for a malignancy within the previous 5 years

• history of an invasive malignancy (other than this prostate cancer,or basal or squamous skin cancers) within prior 5 years

• hormone ablation for 2 months prior to treatment or during treatment

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Neoplasms
• Prostatic Neoplasms

Intervention

Radiation:
• "TrueBeam" stereotactic body radiosurgery
36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study.

Locations

Country	Name	City	State
United States	Lankenau Medical Center, Radiation Oncology	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Albert DeNittis

Country where clinical trial is conducted

United States, 

References & Publications (1)

King CR, Lehmann J, Adler JR, Hai J. CyberKnife radiotherapy for localized prostate cancer: rationale and technical feasibility. Technol Cancer Res Treat. 2003 Feb;2(1):25-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute and late GI/GU toxicity rate following treatment	The study is designed to test the null hypothesis that the acute and late GI/GU toxicity rate 5 years following treatment is greater than 10% versus the alternative hypothesis that the toxicity rate is less than or equal to 10%. The sample size is determined such that there is 90% probability, or power, of identifying excessive toxicity if the true toxicity rate is 20% at the one-sided 5% significance level.	5 years	Yes
Secondary	a comparison of biochemical disease free survival in low risk patients treated with TrueBeam compared to (historical) biochemical disease free survival in patients treated with dose-escalated external beam radiation therapy	For the low-risk cohort, the study is powered to compare 5-year bDFS rates observed with TrueBeam STx to 5-year bDFS rates reported with dose-escalated external beam RT. In Beaumont's monotherapy HDR series treating LR patients, 5-yr ASTRO bDFS was 98%; in Demanes' series of 75% LR and 25% IR, this was 96%. Since TB delivers doses similar to HDR monotherapy, a conservative estimate of the success rate for TB is 97.5% for LR patients.	5 years	No